Effectiveness of a guided mobile app intervention for depression and anxiety in university students (PROMES-U study): protocol of a multicenter randomized controlled trial

Abstract

Background: Symptoms of depression and anxiety are common among Spanish university students. Minimally guided online interventions have shown promise in reducing symptomatology and preventing increased mental distress. Here we describe the protocol of a controlled study which aims to evaluate the effectiveness of a guided preventive mental health intervention for depression and anxiety in Spanish university students. Methods: Ongoing two-arm multicenter randomized controlled trial (RCT) targeting undergraduate students from 6 public universities with symptoms of depression and/or anxiety. Students are evaluated (between February and November 2024) through a web-based survey assessing mental health problems, use of mental health services, self-perceived health, childhood and adolescent adversities, recent stressful events, social networks, university experiences, as well as sociodemographic variables. A total of 428 students, fulfilling the inclusion criteria, are randomly assigned to: intervention group (minimally guided mhealth prevention intervention) or control group (treatment as usual plus self-monitoring including periodic evaluations on mood and stress). The intervention is based on cognitive behavioral therapy principles, such as relaxation and cognitive restructuring, and includes weekly asynchronous feedback from a psychologist based on content and participation, along with self-monitoring. Participants are assessed at baseline, and 3, 6 and 12 months after randomization. The primary outcome consists of the reduction of depressive and/or anxiety symptoms post-intervention, assessed with the Patient Health Questionnaire-9, the Generalized Anxiety Disorder-7 and the Patient Health Questionnaire-Anxiety and Depression Scale. Secondary outcomes of the RCT will be symptoms of other mental health conditions, psychological wellbeing, academic stress, acceptability and adherence. Primary analyses will be conducted on an intention-to-treat basis. Discussion: The results of the PROMES-U RCT will provide valuable information on the effectiveness of a minimally guided preventive mental health intervention to reduce symptoms of depression and anxiety among university students that could be delivered in the campus context. Results will also provide information on the potential impact of the intervention on other relevant factors involved in mental health among university students and on the acceptability and adherence of this intervention. Trial registration number: NCT06078007.